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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02985957




Registration number
NCT02985957
Ethics application status
Date submitted
22/11/2016
Date registered
7/12/2016
Date last updated
9/05/2024

Titles & IDs
Public title
A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)
Scientific title
A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
2016-001928-54
Secondary ID [2] 0 0
CA209-650
Universal Trial Number (UTN)
Trial acronym
CheckMate 650
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Other - Ipilimumab
Treatment: Drugs - Cabazitaxel
Treatment: Drugs - Prednisone

Experimental: Cohort A (Arm A) -

Experimental: Cohort B (Arm B) -

Experimental: Cohort C (Arm C) -

Experimental: Cohort D (Arm D1) -

Experimental: Cohort D (Arm D2) -

Experimental: Cohort D (Arm D3) -

Experimental: Cohort D (Arm D4) -


Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Other: Ipilimumab
Specified dose on specified days

Treatment: Drugs: Cabazitaxel
Specified dose on specified days

Treatment: Drugs: Prednisone
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) Cohorts B and C Per BICR
Timepoint [1] 0 0
From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)
Primary outcome [2] 0 0
Objective Response Rate (ORR) Cohort D
Timepoint [2] 0 0
From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)
Primary outcome [3] 0 0
Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR
Timepoint [3] 0 0
From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Primary outcome [4] 0 0
Radiographic Progression-Free Survival (rPFS) for Cohort D
Timepoint [4] 0 0
From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)
Secondary outcome [1] 0 0
Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C
Timepoint [1] 0 0
From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Secondary outcome [2] 0 0
Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D
Timepoint [2] 0 0
From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)
Secondary outcome [3] 0 0
Overall Survival (OS) Cohorts B and C
Timepoint [3] 0 0
From first dose to the date of death due to any cause (assessed up to approximately 61 months)
Secondary outcome [4] 0 0
Overall Survival (OS) Cohort D
Timepoint [4] 0 0
From randomization to the date of death due to any cause (assessed up to approximately 61 months)
Secondary outcome [5] 0 0
Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C
Timepoint [5] 0 0
From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Secondary outcome [6] 0 0
Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D
Timepoint [6] 0 0
From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Secondary outcome [7] 0 0
The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C
Timepoint [7] 0 0
From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Secondary outcome [8] 0 0
The Number of Participants Experiencing Adverse Events (AEs) in Cohort D
Timepoint [8] 0 0
From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Secondary outcome [9] 0 0
The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C
Timepoint [9] 0 0
From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Secondary outcome [10] 0 0
The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D
Timepoint [10] 0 0
From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Secondary outcome [11] 0 0
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C
Timepoint [11] 0 0
From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Secondary outcome [12] 0 0
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D
Timepoint [12] 0 0
From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Secondary outcome [13] 0 0
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
Timepoint [13] 0 0
From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months)
Secondary outcome [14] 0 0
The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
Timepoint [14] 0 0
From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).
Secondary outcome [15] 0 0
The Number of Participants Who Died in Cohorts A, B and C
Timepoint [15] 0 0
From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months).
Secondary outcome [16] 0 0
The Number of Participants Who Died in Cohort D
Timepoint [16] 0 0
From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).
Secondary outcome [17] 0 0
The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
Timepoint [17] 0 0
From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Secondary outcome [18] 0 0
The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
Timepoint [18] 0 0
From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Secondary outcome [19] 0 0
The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C
Timepoint [19] 0 0
From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Secondary outcome [20] 0 0
The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
Timepoint [20] 0 0
From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Secondary outcome [21] 0 0
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
Timepoint [21] 0 0
From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)
Secondary outcome [22] 0 0
The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
Timepoint [22] 0 0
From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)
Secondary outcome [23] 0 0
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C
Timepoint [23] 0 0
At baseline and Week 4 (Cycle 2)
Secondary outcome [24] 0 0
Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D
Timepoint [24] 0 0
At baseline and 4 weeks after first dose.
Secondary outcome [25] 0 0
Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D
Timepoint [25] 0 0
At baseline and 4 weeks after first dose.
Secondary outcome [26] 0 0
Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C
Timepoint [26] 0 0
At baseline and at Week 4 of Cycle 2.
Secondary outcome [27] 0 0
Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D
Timepoint [27] 0 0
At baseline and 4 weeks after first dose.

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
* Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of =1.73nmol/L (50ng/dL)

For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

* Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Presence of visceral metastases in the liver
* Active brain metastases or leptomeningeal metastases
* Active, known, or suspected autoimmune disease or infection
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

* Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab
* Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel)

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/01/2025
Actual
Sample size
Target
Accrual to date
Final
351
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0027 - Gosford
Recruitment hospital [2] 0 0
Local Institution - 0059 - Wahroonga
Recruitment hospital [3] 0 0
Local Institution - 0029 - Westmead
Recruitment hospital [4] 0 0
Local Institution - 0028 - Southport
Recruitment hospital [5] 0 0
Local Institution - 0043 - Woolloongabba
Recruitment hospital [6] 0 0
Local Institution - 0030 - Elizabeth Vale
Recruitment hospital [7] 0 0
Local Institution - 0031 - Clayton
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2076 - Wahroonga
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
4012 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Denmark
State/province [14] 0 0
Midtjylland
Country [15] 0 0
Denmark
State/province [15] 0 0
Aalborg
Country [16] 0 0
Denmark
State/province [16] 0 0
Kobenhavn O
Country [17] 0 0
Denmark
State/province [17] 0 0
Odense
Country [18] 0 0
France
State/province [18] 0 0
Clermont-ferrand
Country [19] 0 0
France
State/province [19] 0 0
Lyon
Country [20] 0 0
France
State/province [20] 0 0
Marseille Cedex 9
Country [21] 0 0
France
State/province [21] 0 0
Villejuif
Country [22] 0 0
Germany
State/province [22] 0 0
Niedersachsen
Country [23] 0 0
Germany
State/province [23] 0 0
Braunschweig
Country [24] 0 0
Germany
State/province [24] 0 0
Dresden
Country [25] 0 0
Germany
State/province [25] 0 0
Herne
Country [26] 0 0
Germany
State/province [26] 0 0
Jena
Country [27] 0 0
Germany
State/province [27] 0 0
Muenster
Country [28] 0 0
Germany
State/province [28] 0 0
Munich
Country [29] 0 0
Germany
State/province [29] 0 0
Nuernberg
Country [30] 0 0
Germany
State/province [30] 0 0
Nuertingen
Country [31] 0 0
Germany
State/province [31] 0 0
Rostock
Country [32] 0 0
Germany
State/province [32] 0 0
Tuebingen
Country [33] 0 0
Germany
State/province [33] 0 0
Wesel
Country [34] 0 0
Italy
State/province [34] 0 0
Arezzo
Country [35] 0 0
Italy
State/province [35] 0 0
Milano
Country [36] 0 0
Italy
State/province [36] 0 0
Napoli
Country [37] 0 0
Italy
State/province [37] 0 0
Parma
Country [38] 0 0
Italy
State/province [38] 0 0
Terni
Country [39] 0 0
Poland
State/province [39] 0 0
Malopolskie
Country [40] 0 0
Poland
State/province [40] 0 0
Koszalin
Country [41] 0 0
Poland
State/province [41] 0 0
Warszawa
Country [42] 0 0
Spain
State/province [42] 0 0
Sede Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Badajoz
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Spain
State/province [46] 0 0
Malaga
Country [47] 0 0
Spain
State/province [47] 0 0
Santiago Compostela

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02985957